← Product Code [BTR](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR) · K842635

# SHERIDAN/ENDO-PAK (K842635)

_Sheridan Catheter Corp. · BTR · Jul 25, 1984 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR/K842635

## Device Facts

- **Applicant:** Sheridan Catheter Corp.
- **Product Code:** [BTR](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR.md)
- **Decision Date:** Jul 25, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5730
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR/K842635](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR/K842635)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com